The process for assessment of applications for inclusion on the Medicare Benefits Schedule is rigorous and can involve a large investment by both applicants and government to prepare items for assessment by MSAC. For genetic testing MSAC has routinely been asked to assess applications on a gene by gene approach.
The Department of Health (DOH) has commissioned a project to be led by the Royal College of Pathologists of Australasia (RCPA) to develop and pilot an alternative to the assessment of genetic tests by using a disease-based approach.
The disease-based approach is being piloted with an application for heritable mutations predisposing to cancer. This disease group is defined as and limited to known genes which have a well-established protocol for clinically actionable outcomes. The pilot is intended to be technology and platform agnostic, and will address the advances in genetic testing in the clinical environment.
The desired outcome is to demonstrate that a disease based approach is a feasible alternative to the assessment of genetics by MSAC for public funding via the MBS. It is also envisaged that this could result in the development of genetic test application guidelines to be used to process future applications. This would also contribute to the integration of advancing genetic testing capabilities in the healthcare system to improve patient management and health outcomes.